FDA Inspection
Steril-Gene Life Sciences Private LtdSteril-Gene Life Sciences Private Ltd – FDA Inspection, Aug 12, 2026
Record Details
This FDA Inspection record concerns Steril-Gene Life Sciences Private Ltd, with an inspection on August 12, 2026, issued by the Office of Inspections and Investigations, covering animal drugs & feeds.
- Inspection Date
- August 12, 2026
- Product Type
- Animal Drugs & Feeds
View Company Profile
ID · 311ad146-281f-4649-a8ee-d4db0252a24f
Inspection Facts
- Inspection number
- 1330818
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Steril-Gene Life Sciences Private Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2025 | Not classified | Office of Inspections and Investigations | |
| November 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2019 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
Other documents for Steril-Gene Life Sciences Private Ltd
- FDA Inspection 1264873 - 2025-03-12
- FDA Inspection 1194139 - 2022-11-25
- FDA Inspection 1114641 - 2019-12-10
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